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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03544346
Other study ID # JCunningham
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 18, 2018
Est. completion date December 15, 2018

Study information

Verified date May 2018
Source University of Dublin, Trinity College
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There has been significant recent interest on the issue of brain health in athletes. Participation in sports is generally viewed as extremely positive. Consistent evidence supports associations among exercise, cognitive vitality, neural functioning and decreased risk of cognitive decline. However, In the last decade, a dramatic shift in both public and scientific perception around the long-term consequences of concussion is evident. Rugby is a popular full-contact sport played throughout the world at varying levels of competition, including professional level. The game exposes players to inherent risk of injury including repetitive head impacts, due to the high number of collisions and tackles involved. Perhaps not surprisingly, given the physical nature of the sport, rugby has one of the highest rates of concussion of all full-contact sports. Evidence from a recent meta-anaysis found the incidence of concussion to be 4.73 per 1000 player match hours. Given the high incidence of concussion that has been reported in the literature to date, the issue of concussion and repeated head impact exposure is of particular concern in rugby.

Comprehensive investigation of cognition in living retired sports persons with previous exposure to repetitive head impact is noticeably lacking in the literature to date. Findings are inconsistent and investigations are shrouded by consistent methodological biases and flaws, reducing the overall quality of the studies. Relatively little research has been conducted on the long-term effects of repetitive mild TBI or sports concussion on the retired athlete's brain health with ageing. The potential long-term consequences are poorly understood and warrant more research. This study aims to investigate the brain health of retired rugby players in comparison to retired rowers who have achieved the same levels of exercise, without exposure to SRCs


Description:

The primary aim of this study is to investigate brain health and wellness of retired professional Irish rugby players in comparison to retired professional Irish rowers.

Objectives:

The objectives will be to:

Obtain detailed demographic and overall health information from the retired rugby players and retired rowers.

Use a battery of cognitive function tests to assess the cognitive health of the retired rugby players and retired rowers.

Obtain blood samples from the retired rugby players and retired rowers in order to test for biomarkers indicative of neurodegenerative disease.

Investigate rugby player's self-report history of sports-related concussion (number and nature of concussions) during their career. Player's self-report will be correlated where possible with established individual player medical data.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 15, 2018
Est. primary completion date December 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Male A retired professional rugby player (no age limit), who has played at least one season of professional rugby. A retired international rower (no age limit), who completed and trained full time for at least one season.

Athletes who have given informed consent and are willing to participate in the study.

Exclusion Criteria:

- You have a history of a non-sports related moderate to severe concussion or brain injury (eg a motor vehicle accident) You have had a concussion in the last year. You have had treatment of chemotherapy or radiotherapy in last 12 months. You have a bleeding disorder (will exclude you from blood sampling only).

Study Design


Related Conditions & MeSH terms

  • Brain Health Retired Elite Athletes

Intervention

Other:
Exploratory brain and general health assessment
Exploratory brain and general health assessment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Dublin, Trinity College

Outcome

Type Measure Description Time frame Safety issue
Primary Brain Health Assessment Investigating cognitive functioning 1 hour
Secondary Concussion History Assessment History of concussion/head impact exposure 20 minutes